Effects of Exercise Training on Respiratory Performance in Patients With Fibrosing Interstitial Lung Diseases

Not Applicable

Completed

• Conditions: Interstitial Lung Disease; Fibrosis Lung; Lung Diseases
• Interventions: Procedure: Exercise aerobic training; Procedure: Upper, lower and breathing (ULB) exercise

• Registration Number: NCT05227443
• Lead Sponsor: Alexandria University

Brief Summary

The current study recruited patients with fibrosing interstitial lung diseases (f-ILD) whatever was the underlying pathology. The investigators aimed to compare the effects of aerobic exercises for lower limbs (LL) versus upper limbs, lower limbs, and breathing exercises (ULB) on the peak exercise measurements that was measured using cardiopulmonary exercise testing (CPET), dyspnea and health related quality of life assessment in this group of patients.

Detailed Description

The investigators conducted a case-control study with a follow up after 6 weeks (short term). All the participants on recruited were evaluated clinically. A high resolution computed tomography (HRCT) scan of the chest was performed to confirm the diagnosis of f-ILD as well as a spirometry. All the patients were subjected to cardiopulmonary exercise testing (CPET), 6-minute walk test (6-MWT), evaluation of dyspnea using mMRC dyspnea scale, and evaluation of health related quality of life using St. George's Respiratory Questionnaire (SGRQ). The control group were followed up by telephone calls. The intervention groups (LL and ULB) were subjected randomly to aerobic exercise training for 6 weeks. After termination of all the session, the patients were re-evaluated clinically and objectively using CPET, 6-MWT, mMRC and SGRQ. Also, we evaluated the outcome of the patients (control and intervention groups) as those who died or reported exacerbation of the underlying disease were recorded.

Study Timeline

• Study Start: 2020-01-16
• Primary Completion: 2021-04-30
• Study Completion: 2021-07-30
• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2022-01-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-06
• Study First Posted: 2022-02-07
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Adult patients aged ≥ 18 years.
• Fibrosis interstitial lung diseases (f-ILDs) diagnosed based on HRCT radiological features.
• Restrictive or mixed pattern in forced spirometry test

Exclusion Criteria

• Motor disabilities
• Cardiovascular diseases (as acute heart failure, unstable angina or recent myocardial infarction)
• Cognitive impairments
• History of cerebrovascular accident
• Active cancer
• Life expectancy less than 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower limb (LL) exercise training	Exercise aerobic training	All the participants in this modality of training were subjected to only lower limbs aerobic exercise training.
Upper, lower and breathing (ULB) exercise training	Upper, lower and breathing (ULB) exercise	All the participants in this modality of training were subjected to upper and lower limb aerobic exercise training as well as breathing training.

Primary Outcome Measures

Name	Time	Method
Maximum oxygen consumption	6 weeks	Cardiopulmonary exercise testing (CPET) was used to assess the improvement of maximum oxygen consumption.
Quality of life evaluation	6 weeks	St. George's Respiratory Questionnaire (SGRQ) was used to assess the health related quality of life. SGRS constitutes 50 items and the score ranging from 0 to 100, with higher scores indicating more limitations.

Secondary Outcome Measures

Name	Time	Method
Dyspnea	6 weeks	mMRC dyspnea scale (ranging from 0 (the best) - 4 ( the worst) was used to evaluate the improvement of dyspnea.
Resting oxygen saturation	6 weeks	Pulse oximeter was used to assess the change in oxygen saturation (SaO2) at rest after termination of exercise sessions. SaO2 is presented as percentage (%).

Trial Locations

Locations (1)

Faculty of medicine, Alexandria University; 🇪🇬 Alexandria, Egypt